Dukal Corp.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
12
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0233-2018Class IIBLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterJune 1, 2017
D-1675-2012Class IIZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), June 14, 2012
D-1676-2012Class IIDukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000June 14, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K233262Dukal SMS Sterilization WrapMarch 22, 2024
K083320DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPEMarch 6, 2009
K070407DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLMarch 26, 2007
K061864DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560September 15, 2006
K020726DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGEMay 15, 2002
K984564ETHYL CHLORIDE DISPENSERDecember 2, 1999
K970457DUKAL ABD COMBINE PADMay 8, 1997
K970455DUKAL NON ADHERENT DRESSINGMay 8, 1997
K955476DUKAL TRANSPARENT WOUND DRESSINGJanuary 18, 1996
K940440DUKAL NON-WOVEN GAUZEMarch 9, 1994
K936095GAUZE SPONGEFebruary 2, 1994
K931005DUKAL SKIN CLOSURE STRIPJuly 14, 1993